The Becton Dickinson Saf-T-Intima has been adopted widely as an alternative to steel-needle butterfly-style devices, for use in subcutaneous infusions, paediatrics (or example, in scalp veins). Many hospitals have adopted it as a Health & Safety measure, as it eliminates a needle-stick/sharps injury risk associated with blood-contaminated steel cannula.

However, when SMTL approached BD in May 2010, we were informed by their Marketing Integration Manager that:

"Although the device may be suitable for certain alternative applications, its intended purpose is for vascular access and this is clearly indicated in the product labelling.

The BD Saf-T-Intima(TM) is a CE marked device and has been demonstrated to be both safe and effective for its intended purpose (vascular access). It's use in other applications has not bee (sic) proven, i.e., through appropriate clinical evaluations , to enable BD to widen the scope of its intended use."

It is clear that many UK healthcare institutions use the Saf-T-Intima for sub-cutaneous and scalp vein access. A number of articles and documents from various institutions both document and recommend its usage:

The BD Saf-T-Intimaâ„¢ cannula, shown below, is the choice of cannula for SC medications. Discontinue use of metal butterflies as soon as your clinical area has obtained stock of the BDSaf-T-Intimaâ„¢ cannula. The rationale behind this preference is:â€¢ Site reactions are less commonâ€¢ Insertion is less traumatic â€¢ Needle stick injury is reduced to patient and staffâ€¢ Less expensive than alternativesâ€¢ Can remain in situ longer than other devices.

So there are many recommendations regarding its use subcutaneously, and it is already covered for 'vascular' access, but where does this leave UK hospitals who wish to use the product to reduce their risk of needlestick injury ?

There are probably at least 2 alternatives:

Undertake a clinical evaluation.

Undertake a risk analyses, considering the potential benefits of reduced risk for staff and benefits for patients (reduced risk of tissuing for example), but noting that BD themselves do not market the device for these particular uses. If agreed by the local risk manager the hospital may then need to add the usage to their risk register.

Put pressure on BD to commission appropriate trials as necessary, or to have another discussion with their regulatory affairs department to see whether there is now enough evidence around the World for the alternate uses.